Nasopharyngeal Carcinoma Patients Treated With Curative RadiotherapyNCT06348485
Massive Nasal Bleeding in Patients With NPC Received Curative RT
An observational study of Nasopharyngeal Carcinoma Patients Treated With Curative Radiotherapy, run by Taichung Veterans General Hospital at 1 site in Taiwan.
Trial summary
To investigate the incidence, predictive markers, and survival impact of massive nasal bleeding in nasopharyngeal carcinoma (NPC) patients who received curative radiotherapy (RT) with/without chemotherapy. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Nasopharyngeal Carcinoma Patients Treated With Curative Radiotherapy
- What is being tested?
- Patients without massive nasal bleeding and Patients with massive nasal bleeding
- How many people
- 1,327 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Dec 1994to 29 Feb 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: A total of 1327 patients with previously untreated, biopsy-proven NPC, and no distant metastasis were retrospective reviewed. There are 957 males and 370 females received conventional 2D or 3D conformal radiotherapy.
Who may be able to join
- previously untreated, biopsy-proven NPC
- no distant metastasis
Who cannot join
- incomplete record of history or treatment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Massive Nasal Bleeding in Patients With Nasopharyngeal Carcinoma Received Curative Radiotherapy
To investigate the incidence, predictive markers, and survival impact of massive nasal bleeding in nasopharyngeal carcinoma (NPC) patients who received curative radiotherapy (RT) with/without chemotherapy. A total of 1327 patients with previously untreated, biopsy-proven NPC, and no distant metastasis were retrospective reviewed. Investigators analyzed the occurrence rates of massive nasal bleeding between different characteristics and tried to identify important predictive factors. Investigators compared overall survival between patients with and without massive nasal bleeding by Kaplan-Meier method.
- Being tested
- Patients without massive nasal bleeding, Patients with massive nasal bleeding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patients without massive nasal bleedingOther
No event of massive nasal bleeding after curative radiotherapy
Patients with massive nasal bleedingOther
Any event of massive nasal bleeding after curative radiotherapy
| Study group | Role | What they receive |
|---|---|---|
| NPC received Curative radiotherapy | Not described Receives: Other: Patients without massive nasal bleeding; Other: Patients with massive nasal bleeding |
What is being measured
The primary outcome is the main question the study is designed to answer.
Massive Nasal Bleeding Rate
Massive Nasal Bleeding Rate among different characteristics. Massive Nasal Bleeding was defined as unique blood loss > 300 ml or recurrent blood losses > 100 ml.
Measured: From date of radiotherapy until the date of first documented massive bleeding, assessed up to 360 months
Secondary outcomes (1)
Overall Survival
Overall Survival
Measured: From date of radiotherapy until the date of last clinic visit or date of death from any cause, whichever came first, assessed up to 360 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2024
- Study start1 Dec 1994
- Primary completion30 Apr 2019
- Study completion29 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Nasopharyngeal Carcinoma Patients Treated With Curative RadiotherapyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 1,327 participants (actual)
Sponsor and investigators
- Lead sponsor
- Taichung Veterans General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hao-Shen Cheng, Taichung Veterans General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06348485
- Sponsor's protocol ID
- VGHTCCTC_NPCbleeding001
- Status last verified
- Mar 2024
- First submitted
- 21 Mar 2024
- Last updated
- 4 Apr 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Huang Y, Yan D, Wang M, Chen S, Yang F. Clinicopathological factors affecting the prognosis of massive hemorrhage after radiotherapy for patients having nasopharyngeal carcinoma. J Cancer Res Ther. 2021 Nov;17(5):1219-1224. doi: 10.4103/jcrt.jcrt_586_21.
PubMed 34850770Zhan J, Zhang S, Wei X, Fu Y, Zheng J. Etiology and management of nasopharyngeal hemorrhage after radiotherapy for nasopharyngeal carcinoma. Cancer Manag Res. 2019 Mar 15;11:2171-2178. doi: 10.2147/CMAR.S183537. eCollection 2019.
PubMed 30936749Li J, Yi X, He G, Yao D, Bin X, Feng Y, Niu Z, Tan Q, Tang A. Analysis of the risk of death and clinical management for nasal or nasopharyngeal bleeding occurring after radiotherapy for nasopharyngeal carcinoma. Auris Nasus Larynx. 2022 Aug;49(4):703-708. doi: 10.1016/j.anl.2022.01.006. Epub 2022 Jan 20.
PubMed 35065845Zeng L, Wan W, Luo Q, Jiang H, Ye J. Retrospective analysis of massive epistaxis and pseudoaneurysms in nasopharyngeal carcinoma after radiotherapy. Eur Arch Otorhinolaryngol. 2022 Jun;279(6):2973-2980. doi: 10.1007/s00405-021-07111-x. Epub 2021 Oct 8.
PubMed 34623497
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Massive Nasal Bleeding in Patients With Nasopharyngeal Carcinoma Received Curative Radiotherapy
- ClinicalTrials.gov ID
- NCT06348485
- Acronym / sponsor ID
- VGHTCCTC_NPCbleeding001
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,327 participants (actual)
- Lead sponsor
- Taichung Veterans General HospitalUniversity, hospital or other
- Study start
- 1 Dec 1994 (actual)
- Primary completion
- 30 Apr 2019 (actual)
- Study completion
- 29 Feb 2024 (actual)
- First posted
- 4 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To investigate the incidence, predictive markers, and survival impact of massive nasal bleeding in nasopharyngeal carcinoma (NPC) patients who received curative radiotherapy (RT) with/without chemotherapy. A total of 1327 patients with previously untreated, biopsy-proven NPC, and no distant metastasis were retrospective reviewed. Investigators analyzed the occurrence rates of massive nasal bleeding between different characteristics and tried to identify important predictive factors. Investigators compared overall survival between patients with and without massive nasal bleeding by Kaplan-Meier method.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| NPC received Curative radiotherapy | – | Other: Patients without massive nasal bleeding, Other: Patients with massive nasal bleeding |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- A total of 1327 patients with previously untreated, biopsy-proven NPC, and no distant metastasis were retrospective reviewed. There are 957 males and 370 females received conventional 2D or 3D conformal radiotherapy.
Key inclusion criteria (2 listed)
- previously untreated, biopsy-proven NPC
- no distant metastasis
Key exclusion criteria (1 listed)
- incomplete record of history or treatment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Patients without massive nasal bleedingNo event of massive nasal bleeding after curative radiotherapy | Other | NPC received Curative radiotherapy |
| Patients with massive nasal bleedingAny event of massive nasal bleeding after curative radiotherapy | Other | NPC received Curative radiotherapy |
Primary outcome
Massive Nasal Bleeding Rate
Time frame: From date of radiotherapy until the date of first documented massive bleeding, assessed up to 360 months
Massive Nasal Bleeding Rate among different characteristics. Massive Nasal Bleeding was defined as unique blood loss > 300 ml or recurrent blood losses > 100 ml.
1 secondary outcome
Overall Survival
Time frame: From date of radiotherapy until the date of last clinic visit or date of death from any cause, whichever came first, assessed up to 360 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2024.
- Background: PubMed 34850770Huang Y, Yan D, Wang M, Chen S, Yang F. Clinicopathological factors affecting the prognosis of massive hemorrhage after radiotherapy for patients having nasopharyngeal carcinoma. J Cancer Res Ther. 2021 Nov;17(5):1219-1224. doi: 10.4103/jcrt.jcrt_586_21.
- Background: PubMed 30936749Zhan J, Zhang S, Wei X, Fu Y, Zheng J. Etiology and management of nasopharyngeal hemorrhage after radiotherapy for nasopharyngeal carcinoma. Cancer Manag Res. 2019 Mar 15;11:2171-2178. doi: 10.2147/CMAR.S183537. eCollection 2019.
- Background: PubMed 35065845Li J, Yi X, He G, Yao D, Bin X, Feng Y, Niu Z, Tan Q, Tang A. Analysis of the risk of death and clinical management for nasal or nasopharyngeal bleeding occurring after radiotherapy for nasopharyngeal carcinoma. Auris Nasus Larynx. 2022 Aug;49(4):703-708. doi: 10.1016/j.anl.2022.01.006. Epub 2022 Jan 20.
- Background: PubMed 34623497Zeng L, Wan W, Luo Q, Jiang H, Ye J. Retrospective analysis of massive epistaxis and pseudoaneurysms in nasopharyngeal carcinoma after radiotherapy. Eur Arch Otorhinolaryngol. 2022 Jun;279(6):2973-2980. doi: 10.1007/s00405-021-07111-x. Epub 2021 Oct 8.
- Individual participant dataSharing planned: Undecided
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Nasopharyngeal Carcinoma Patients Treated With Curative Radiotherapy, run by Taichung Veterans General Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Massive Nasal Bleeding Rate (time frame: From date of radiotherapy until the date of first documented massive bleeding, assessed up to 360 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06348485, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Apr 2024.